Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
NCT Number: NCT05918185
This study evaluates the association between a comprehensive geriatric assessment and laboratory biomarkers with the side effects of chemotherapy in older patients with multiple myeloma (MM). The comprehensive geriatric assessment is a tool that can help to determine how fit a patient is. It is composed of a series of questions and tests designed for older people to evaluate their physical function, mental status, mental health, nutritional status, social support, level of social activity, and the presence of other medical problems. In addition to geriatric assessment domains, laboratory biomarkers may provide information on physiologic dysfunction as a measure for evaluation of frailty in the cancer setting. This study will help researchers in the future by predicting which patients will have more side effects with chemotherapy based on their comprehensive geriatric assessment and laboratory biomarkers, which will allow adjustments to treatment in older adult patients with MM.
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Notify Me65 year and older
All sexes
Observational
Rochester, Minnesota, 55905, United States
PRIMARY OBJECTIVE:
I. To evaluate the association between a baseline comprehensive geriatric assessment (cGA) and chemotherapy toxicity in the first 4 months of treatment measured by treatment-related adverse events, patient-reported outcomes (PROs), and treatment discontinuation in older patients (>= 65 years) with multiple myeloma (MM).
SECONDARY OBJECTIVES:
I. To evaluate the association between a baseline cGA and baseline disease- and host- related laboratory characteristics and cytogenetic risk profile by fluorescence in situ hybridization among newly diagnosed older (>= 65 years) patients with MM.
II. To evaluate how the cGA changes over 4 months from the start of treatment and the association between those changes and treatment response in older patients (>= 65 years) with MM.
III. To evaluate the association between proposed frailty biomarkers at baseline and treatment toxicity in the first 4 months of treatment measured by treatment-related adverse events, PROs, and treatment discontinuation in older (>= 65 years) patients with MM.
OUTLINE: This is an observational study.
Patients complete surveys and undergo cGA, blood sample collection, and electronic health record (EHR) review on study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo blood sample collection
Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo cGA
Medical records are reviewed
Complete surveys
Time frame: Up to 4 months
Will graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The maximum observed grade per adverse event and capture grade >= 3 toxicities.
Time frame: Up to 4 months
Will be analyzed longitudinally using toxicity over time analysis which measures adverse events over time, providing information on timing and evolution of symptoms during treatment.
Time frame: Up to 4 months
Will be assessed at the end of each treatment cycle (prior to each new cycle) at scheduled visits for a total of 4 months or until treatment discontinuation whichever comes first using the PRO Measurement Information System Global Health which is a 10-item questionnaire that assesses a patient's global heath. All questions have a five-point Likert-type scale, except for the rating of pain question which has a 10-point scale. Subscale scores can be generated for Global Physical Health and Global Mental for each patient.
Time frame: Up to 4 months
Select PRO-CTCAE symptomatic adverse event items to assess the presence, severity and interference of symptoms experienced by patients.
Mayo Clinic
Other
The Role of the Comprehensive Geriatric Assessment in Elderly Patients With Multiple Myeloma: A Single Center Prospective Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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